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Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

Primary Purpose

Infantile Colic, Colic, Infantile

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Bifidobacterium, BB-12® (Bifidolactis Infant)

Bifidolactis Infant Placebo

About this trial

This is an interventional treatment trial for Infantile Colic focused on measuring Bifidobacterium

Eligibility Criteria

undefined - 7 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients are included in the study if they meet all the following criteria:

Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
Diagnosis of IC according to Rome III criteria.
Written informed consent of the parent/tutor.

Exclusion Criteria:

Patients are excluded from this study if they meet any of the following criteria:

Birth weight < 2500 g.
Gestational age < 37 weeks.
APGAR 5 minutes < 7.
Formula feeding.
Stunting/loss of weight (< 100 g/weeks from birth to the last reported weight).
Neurological diseases.
Known or suspected food allergy.
Gastroesophageal reflux disease.
Use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment.
History of fever and/or infectious diseases in the last 2 weeks prior to enrollment.
Ongoing systemic infections.
History of congenital infections.
Chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency)
Primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation).
Metabolic diseases.
Genetic diseases and chromosomal abnormalities.
Primary or secondary immunodeficiencies.
Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol.
Previous participation in this study.

Sites / Locations

Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;

patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.

Outcomes

Primary Outcome Measures

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration

Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)

Secondary Outcome Measures

Number of Crying Episodes

Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too.

Infectious Diseases Incidence

Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations".

Bowel Evacuation - Stool Frequency

Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.

Bowel Evacuation - Stool Consistency

Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows: Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed"

Infant's Mood

The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week. Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed".

Infant's Sleep

Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.

Infant's Temper

Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.

Infant's Feeding

Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.

Calprotectin

Evaluation of calprotectin levels in fecal samples

Beta-defensin Type 2

Evaluation of Beta-defensin type 2 levels in fecal samples

LL37 Peptide

Evaluation of LL37 peptide levels in fecal samples

Short Chain Fatty Acids - Butyrate

Evaluation of Butyrate levels in fecal samples

Secretory Immunoglobulin A (SIgA)

Secretory immunoglobulin A (SIgA) levels in fecal samples

Full Information

NCT ID

NCT03434249

First Posted

February 9, 2018

Last Updated

January 13, 2020

Sponsor

SOFAR S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT03434249

Brief Title

Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

Official Title

Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 11, 2016 (Actual)

Primary Completion Date

November 6, 2017 (Actual)

Study Completion Date

November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOFAR S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infantile Colic, Colic, Infantile

Keywords

Bifidobacterium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a prospective randomized double blind placebo controlled clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;

Arm Title

Group II

Arm Type

Placebo Comparator

Arm Description

patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacterium, BB-12® (Bifidolactis Infant)

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidolactis Infant Placebo

Primary Outcome Measure Information:

Title

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration

Description

Time Frame

at 28 days from the baseline (Visit T5)

Secondary Outcome Measure Information:

Title

Number of Crying Episodes

Description

Time Frame

at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

Title

Infectious Diseases Incidence

Description

Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations".

Time Frame

at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)

Title

Bowel Evacuation - Stool Frequency

Description

Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.

Time Frame